USFDA nod to Pfizer, Moderna for immunocompromised individuals

The US Food and Drug Administration (FDA) has amended the emergency use authorizations for the Pfizer and the Moderna Covid-19 vaccines to allow people with compromised immune systems to get the third dose.

“Today, FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals,” US FDA tweeted.

“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” FDA’s acting commissioner said.

The decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to help those patients with immune deficiencies who are considered most likely to benefit from an additional shot. An estimated 2.7 per cent of adults in the United States are immunocompromised, according to the CDC.

Specifically, these immunocompromised individuals are solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, the US FDA said.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of the covid-19 vaccine at this time,” acting FDA Commissioner said.

Medically Speaking Team

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